BCG

What is the most important information I should know about BCG?

You should not receive BCG if you have tuberculosis, a fever, a bladder infection, blood in your urine, or a weak immune system (caused by disease or by using certain medicines).

You should also not receive BCG if you have had a bladder biopsy, surgery, or catheter within the past 14 days.

Serious and sometimes fatal infections may occur during treatment with BCG. Stop using this medicine and call your doctor right away if you have signs of infection (fever, chills, body aches).

What is BCG?

BCG (Bacillus Calmette and Guérin) is a freeze-dried product made from bacteria. BCG increases certain white blood cells that destroy invading tumor cells in the bladder.

BCG is used to treat bladder cancer that is localized (has not spread to other parts of the body).

BCG may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before I receive BCG?

You should not receive this medication if you are allergic to BCG, or if you have:

tuberculosis;

a weak immune system from diseases such as AIDS, leukemia, or lymphoma;

a fever, a bladder infection, or blood in your urine;

if you are using steroids or receiving chemotherapy or radiation treatments; or

if you have had a bladder biopsy, surgery, or catheter within the past 14 days.

To make sure BCG is safe for you, tell your doctor if you have:

any type of bacterial, fungal, or viral infection (including HIV);

myasthenia gravis;

a pacemaker or other artificial heart device;

an artificial joint or other prosthetic;

a history of aneurysm (dilated blood vessel);

if you have ever had bypass surgery;

if you have ever had tuberculosis; or

if you need to have an organ transplant (kidney, liver, heart, etc).

FDA pregnancy category C. It is not known whether BCG will harm an unborn baby. Use effective birth control to prevent pregnancy while receiving BCG. Tell your doctor if you become pregnant during treatment.

It is not known whether BCG passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is BCG given?

BCG is injected directly into the bladder using a catheter inserted into the urethra (the tube for passing urine out of your bladder). You will receive this medication in a clinic or hospital setting.

BCG is usually given once every week for 6 weeks, and then given every 3 to 6 months for up to 2 years. Follow your doctor's instructions about your specific dosing schedule.

After BCG is placed into the bladder, you will need hold the medication in your bladder as long as possible up to 2 hours. During that time you may be encouraged to lie down or stay relaxed.

For at least 6 hours after you are treated with BCG, your urine will still contain some of the medication and the bacteria it is made from. To prevent the spread of this bacteria, use a toilet rather than a urinal, and sit on the toilet while urinating.

Before you flush the toilet, disinfect the urine with household bleach in an amount that is approximately equal to how much you have urinated. Pour the bleach into the toilet in which you urinated, let it stand for 15 minutes and then flush.

Your doctor may ask you to drink extra fluids for several hours after your BCG treatment to help flush out your bladder. Follow your doctor's instructions.

Call your doctor right away if you have a fever after receiving BCG, especially if the fever lasts for several hours or longer.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using BCG.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your BCG treatment.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving BCG?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

What are the possible side effects of BCG?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect BCG?

If you have an infection that must be treated with an antibiotic, you may need to stop receiving BCG for a short time. Antibiotics can make BCG less effective and should be avoided during your treatment with BCG. Follow your doctor's instructions and be sure to tell any other doctor who treats you that you are receiving BCG.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with BCG, especially an antibiotic, or any drugs that weaken your immune system, such as:

cancer medicine or radiation;

medicine to prevent organ transplant rejection;

medicines to treat multiple sclerosis, psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

tuberculosis medication--pyrazinamide, rifampin, rifabutin.

This list is not complete. Other drugs may interact with BCG, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your doctor or pharmacist can provide more information about BCG.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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